Inside the World of Counterfeit Drugs

July 24, 2009

Part 2: The European Repackaging Debate – Last week we witnessed the confusing practice of repackaging of prescription medicines within the European Union (EU) through the eyes of a fictitious Dutch patient picking up his blood pressure tablets at a city retail pharmacy. The patient’s experience is shared by millions of Europeans living in Germany, Great Britain, and Holland among other countries. Under current EU rules, medicines can be re-boxed or re-labeled after they leave the site of production, and tablets can be removed from their blisters and reconditioned. Counterfeiters can exploit this fact in order to sneak their fake goods past regulators. One of the prime sources of counterfeit medicines, which can enter the drug supply at the point of repackaging, is the Internet.

For the past decade, the World Health Organization (WHO) has argued forcibly against the risks of Internet sales of prescription medicines. The WHO notes that such Internet suppliers can easily circumvent national regulatory authorities. This allows them to introduce fake and unapproved medicines into the supply chain – medicines which do not work, or worse, are unsafe. Since that time, there have been several, highly publicized incidents where counterfeit drugs originating in Pakistan, India and China have been uncovered in the United Kingdom and elsewhere in Europe. No longer limited to the so-called “lifestyle” drugs, counterfeit drugs are currently dispensed for medications to combat osteoporosis, high blood pressure, high cholesterol and a wide array of other conditions.

Citing a clear and present danger to the public health due to counterfeits, the European Federation of Pharmaceutical Industries and Associations (EFPIA) – a member of the Partnership for Safe Medicines (PSM) – has argued that they are prepared to make the necessary investments in packaging technology to dramatically reduce the incidence of counterfeiting in Europe. EFPIA considers a repackaging ban the single most powerful tool to prevent counterfeits. In order to establish a so-called “electronic pedigree” for medicines, they also urge the use of unique pack-level identifiers, such as the 2D matrix barcode. Finally, the industry association supports clear liabilities for all parties involved in the supply chain, stiffer penalties for counterfeiters and a consumer education program about the dangers of using Internet pharmacies.

Despite this warning, when confronted with this major public health concern last December, the European Commission punted. In a compromise decision, they declined to ban the repackaging of medicines at this time. Instead they issued broad guidelines to address the growing concerns about the counterfeit medicines threat in Europe. In explaining the consensus decision, Vice President Guenter Verheugen stated that “if Europe is to be the chemist shop of the world, we need to do more”.

The broad guidelines are a good start and include monitoring of dubious parallel importers, barcodes to allow track and trace and a seal on the outer package. Implementation details are expected to be enumerated next year at the earliest.

Next week, hear more from guest blogger Gregory N. Zec in part 3 of Insidethe World of Counterfeit Drugs.